Box for transporting samples

ABSTRACT

The present invention relates to a box for transporting samples, conceived to maintain the temperature in its interior in a range between 15° C. and 25° C. for an extended time period and suitable for any product that requires thermal and mechanical resistance, particularly for biological samples. The transport box of the invention comprises a series of non-primary packaging of carefully selected dimensions, shape and materials, accumulating heat elements and, optionally, filling material.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is filed under the provisions of 35 U.S.C. §119(e) andclaims the priority of U.S. Provisional Patent Application No.61/085,433 filed on Aug. 1, 2008, which is incorporated by referenceherein in its entirety.

DESCRIPTION

The present invention relates to a box for transporting samples, devisedto maintain the temperature in its interior in a range between 15° and25° C. for extended time periods.

The transport box of the invention is particularly suitable fortransporting biological samples, although it is applicable in general tothe transport of any product that requires extreme thermal andmechanical resistance.

BACKGROUND OF THE INVENTION

According to the ICAO (International Civil Aviation Organization), thespecific definition of biological sample is any material of human oranimal origin that includes, but is not limited to, excreta, secreta,blood and its components, tissues and their fluids, sent for diagnosticpurposes, but excluding infected live animals. This definition includesall the typical samples used for the diagnosis or analysis carried outin clinical or experimental laboratories (blood, serum, saliva, urine,faeces, CSF, biopsies, histology, swabs, etc.).

In general, the transport of products always entails risks of thermaland mechanical type. Optimum packaging is that which effectivelyprevents both risks, thereby allowing the temperature of the biologicalsample to remain within an optimum range, as it is packaged at originuntil it is received at its destination and protected from mechanicaldamages. An optimum temperature range is understood as that temperaturerange which guarantees the physical-chemical properties that ensure thefeasibility and repeatability of the aforementioned experiments.

Due to being a biological sample, the packaging must also comply withcertain biological protection requirements. The samples or biologicalproducts, in general, naturally entail an associated biological risk inaccordance with the biological load they contain. Consequently thepackaging, apart from preventing mechanical damage, is vital to theprevention of biological risk.

In general, the receptacles used to transport biological samples arecomprised of a primary packaging and one or several non-primarypackaging. Throughout this description, the definitions of the termsexplained below shall be used.

A primary packaging is that which contains the biological product fordiagnosis. Said packaging must be standardized and meet the requirementsestablished in the packaging instructions. In this manner, normally, theprimary packaging must fulfill two requirements: contain a plasticmaterial that envelops and waterproofs the biological sample and containprinted information guaranteeing the standardized biological product inits interior.

Non-primary packaging are those which, at least, contain the primarypackaging. They can be secondary, tertiary, etc. depending on whetherthey contain one, two or more packaging in their interior. Thesepackaging do not need to be standardized.

In this manner, the biological sample may be introduced directly in atube or a standardized receptacle, although said sample would normallybe introduced in a standardized plastic bag with safety seal. Anotherpossibility would be to place the biological sample inside anon-standardized plastic bag, with a safety seal, inside a more complexstandardized receptacle with some type of coating for mechanical and/orthermal protection.

Filling material is understood to be the material which is disposed inthe space between the different packaging. This material isfundamentally aimed at reducing mechanical and thermal stress, such asexpanded polystyrene chips or different insulating materials of a highlyplastic nature and with very low thermal conductivity, in addition tomaterials with low calorific capacity which, once heated or cooled at adetermined temperature, help to maintain the surrounding space at aspecific temperature. Additionally, filling of absorbent materials maybe used (for example, cotton or vermiculite) to guarantee the suitablehumidity conditions and/or to absorb, in case of accident, liquidmaterial spills.

In the current state of the art there are different types of containersconceived to conserve biological samples within a pre-establishedtemperature range, normally cold (between −20° C. and 4° C.). Theseinclude containers equipped with electrical systems fed by an externalpower supply, containers equipped with cold-accumulating elements andcontainers equipped with an autonomous mechanical system thatdistributes the cold evenly throughout the container.

The containers included in the State of the Art have certaindeficiencies with respect to their use for transporting a sample attemperatures in a range between 15° C. and 25° C., such as thefollowing:

-   -   in extreme temperature conditions (T_(external)<10° C. or        T_(external)>30° C.) they do not maintain the optimum        temperature range even for short time intervals; and/or    -   in non-extreme temperature conditions (15° C.<T_(external)<25°        C.) they do not maintain the optimum temperature range during        standard time intervals (16-24 hours).

On the other hand, the containers that could be suitable for maintainingthe optimum temperature range during transport of the sample areexpensive systems, with the drawbacks that this entails.

Consequently, a need exists for a suitable container for transportingbiological samples that maintains the temperature in its interior withinthe optimum range for extended time periods, without the financialdetriment associated to prior systems of the State of the Art.

DESCRIPTION OF THE INVENTION

The transport box of the invention has been devised to solve thepreviously expounded problems, maintaining the temperature in itsinterior in a range between 15° C. and 25° C. for an extended timeperiod, understood within the context of this specification as a timeperiod longer than 24 hours.

More specifically, the invention relates to a transport box according toindependent claim 1. Advantageous embodiments are defined by means ofthe dependent claims.

Advantageously, the transport box of the invention is the moststructurally simple and cheap solution to the aforementioned problem.

The transport box of the invention comprises a first non-primarypackaging, a second non-primary packaging, a third non-primary packagingand heat accumulators. The first non-primary packaging is made ofplastic material of high heat-insulating capacity, preferablypolypropylene or other polymer of similar characteristics. With regardto its shape, the first non-primary packaging is preferably cylindricalin shape to contribute to evenly distribute the thermal gradient. In apreferred embodiment, the first non-primary packaging has a doublelayer, in such a manner that it closes hermetically and providessufficient rigidity to protect the interior from possible blows. In apossible embodiment of the transport box of the invention, the interiorof the first non-primary packaging has a metal lining.

The second non-primary packaging is made of high-density polystyrene. Inan embodiment of the invention, the interior of the second non-primarypackaging is lined with a heat-insulating material, for example a layerof cardboard, in order to increase its heat-insulating capacity.

The third non-primary packaging is made of cardboard and its purpose isto sustain the structure of the second non-primary packaging, in orderto increase its thermal resistance and bear the necessary shipmentlabels and documents.

The second and third non-primary packaging shall preferably have astraight parallelepiped shape.

In an alternative embodiment, the second and third non-primary packagingmay be combined in a single packaging with a polystyrene interior andcardboard exterior.

The transport box of the invention also comprises one or several heataccumulators, with the property that their temperature varies veryslowly on exposure to external temperature gradients. These productsgenerally have a gel or liquid form packed in a plastic material.

These heat accumulators, according to the type of product to be shipped,may be disposed inside the first non-primary packaging, between thefirst non-primary packaging and the second non-primary packaging or inboth places.

Preferably, heat accumulators in liquid form enveloped in rigid plasticmaterial or heat accumulators in gel form enveloped in flexible plasticmaterial shall be used.

Additionally, in order to increase the thermal and mechanical resistanceof the box, filling material may be disposed either in the interior ofthe first non-primary packaging, between the first non-primary packagingand the second non-primary packaging, or in both places. In a preferredembodiment, said material consists of porous plastic material chipsapproximately 1 cm³ in volume.

As mentioned earlier, one of the objects of the invention is to providea transport box capable of maintaining a sample disposed in its interiorwithin an optimum temperature range between 15° C. and 25° C. For thispurpose, the materials, dimensions and shapes of the different packagingmust be carefully selected. The temperature in the interior of the firstnon-primary packaging (T₁) is a variable that depends on differentfactors but, for the sake of simplification, we can conclude that T₁depends fundamentally on the temperature in the interior of the secondnon-primary packaging (T₂).

However, the variables defining T₂ are:

-   -   the external ambient temperature,    -   the inclusion or non-inclusion of heat accumulators between the        first non-primary packaging and the second non-primary        packaging,    -   the initial temperature of the heat accumulators,    -   the material of the non-primary packaging used,    -   the shape and dimensions of this packaging,    -   the inclusion or non-inclusion of filling material.

The variable that comprises the greatest number of interconnectionsbetween the different elements of the box is defined within this contextas the relationship (R_(μ)) between the volume of air between the firstnon-primary packaging and the second non-primary packaging (V₁₂) and thetotal volume of the box (V_(tot)):

R _(μ) =V ₁₂ /V _(tot),

with the exception that the thickness of the second non-primarypackaging must also remain within a certain range.

In fact, given that air is a good thermal insulator, the volume of airbetween the first non-primary packaging and the second non-primarypackaging must be sufficient in order to ensure suitable insulation. Thevolume of air between the first non-primary packaging and the secondnon-primary packaging increases as the size of the first non-primarypackaging decreases and as the size of the second non-primary packagingincreases. However, the size of both packaging is conditioned by thetransport needs: the first non-primary packaging must be sufficientlylarge to contain the primary packaging with the biological sample in itsinterior, in addition to heat accumulating elements and/or fillingmaterial, if necessary, and the second non-primary packaging must not beso large as to hinder the handling and transport of the transport box.

On the other hand, as the thickness of the second non-primary packagingincreases, so does the insulating capacity of the transport box.Nevertheless, excessive thickness entails certain drawbacks, such as alarger size of the transport box and an increase in expense associatedto the amount of material used in its manufacture.

Consequently, a compromise must be found between both sizes whendesigning a transport box that suitably meets the needs of thistechnical sector.

Advantageously, the transport box according to the invention resolvesthe aforementioned drawbacks on defining an optimum range for the R_(μ)parameter and for the thickness of the second non-primary packaging.Specifically, in the transport box of the invention, the proportionR_(μ) of volume of air between the first non-primary packaging and thesecond non-primary packaging with respect to the total volume of the boxis comprised within a range between 0.1 and 0.6, and the thickness ofthe second non-primary packaging is in a range between 4 and 6 cm.

In a preferred embodiment of the invention, the parameter R_(μ) iscomprised in a range between 0.2 and 0.5 and, in a preferred embodiment,between 0.2 and 0.3.

In a preferred embodiment of the invention, the thickness of the secondnon-primary packaging is comprised in a range between 4.5 and 5.5. cmand shall be preferably 5 cm.

In a preferred embodiment of the invention, the transport boxadditionally comprises filling material, disposed in the interior of thefirst non-primary packaging, between the first non-primary packaging andthe second non-primary packaging or in both positions.

DESCRIPTION OF THE DRAWINGS

For the purpose of complementing the description hereunder and tofurther explain the characteristics of the invention, a set of drawingsin accordance with a preferred embodiment thereof has been included asan integral part of said description, in which the following figureshave been represented in an illustrative and non-limitative manner:

FIG. 1 shows an exploded view of the transport box according to theinvention;

FIG. 2 shows a time-temperature graph for an external temperature of 4°C. which compares the results of two embodiments of the firstnon-primary packaging of the transport box according to the inventionwith an embodiment of said first non-primary packaging representative ofthe state of the art;

FIG. 3 shows the time-temperature graph for a package sent via a firstroute from Barcelona on 15 Feb. 2005 and received in Tebubio on 16 Feb.2005;

FIG. 4 shows the time-temperature graph for a package sent via a secondroute from Tebubio on 16 Feb. 2005 and received in Lyngby on 17 Feb.2005;

FIG. 5 shows a comparative time-temperature graph of the two routes, theresults of which are represented in FIGS. 3 and 4.

PREFERRED EMBODIMENT OF THE INVENTION

As shown in FIG. 1, the transport box (1) for transporting biologicalproducts according to the invention comprises a first non-primarypackaging (2), a second non-primary packaging (3), a third non-primarypackaging (4) and one or several heat accumulators (5).

The first non-primary packaging (2) is a hermetic receptaclemanufactured from a high-capacity heat-insulating plastic material, tocontain in its interior a primary packaging with the biological sampleto be transported. In the embodiment of FIG. 1, the first non-primarypackaging (2) has a cylindrical shape to contribute to the evendistribution of the thermal gradient. Preferably, the first non-primarypackaging (2) has a radius of approximately 11 cm and a height ofbetween 13 and 18 cm.

The second non-primary packaging (3) contains the first non-primarypackaging (2) and is manufactured in high-density polystyrene. In theembodiment exemplified in FIG. 1, the second non-primary packaging (3)has a straight parallelepiped shape, specifically a prism shape, formedby six polystyrene sheets. In a preferred embodiment, the parallelepipedis 30 cm in width×30 cm in length×20 cm in height. In an alternativeembodiment, the parallelepiped is 40 cm in width×40 cm in length×30 cmin height.

The dimensions of and proportion between the first and secondnon-primary packaging (3) are selected in such a manner as to guaranteethe maintenance of the biological sample within the desired temperaturerange for a time period longer than 24 hours.

The third non-primary packaging (4) contains the second non-primarypackaging (3) to sustain the structure, increase its thermal resistanceand bear the necessary labelling and is manufactured, preferably, fromcardboard. Despite having been defined as two independent packaging, thesecond and third non-primary packaging (4) may be integrated to form asingle packaging with polystyrene interior and cardboard or similarexterior, which allows identifying stickers and labels to be fixedthereon.

The transport box (1) visible in FIG. 1 also contains heat accumulatingelements (5) which, disposed in a suitable number and temperature,inside the first non-primary packaging (2), between the firstnon-primary packaging (2) and the second non-primary packaging (3) or inboth, contribute to maintain the interior of the first non-primarypackaging (2) within the optimum temperature range.

Examples

In order to verify that the transport box (1) of the invention issuitable for transporting a biological sample in a reliable and securemanner, maintaining said sample within the optimum temperature range,between 15° C. and 25° C., for extended time periods, differentexperiments were carried out, described hereunder in the followingexamples:

Example 1 Resistance to a Constant External Temperature of 4° C.

Experimental studies of a transport box (1) according to the invention,with two different types of first non-primary packaging (2), werecarried out with a constant external temperature of 4° C.:

-   -   Type 2 packaging (NPT2): A hermetically sealed receptacle with a        plastic interior and exterior.    -   Type 3 packaging (NPT3): A hermetically sealed receptacle with a        plastic exterior and stainless steel inner lining.        Type 2 and 3 packaging were both cylinders of identical size (22        cm of external diameter and 13.5 cm in height), the only        difference being the inner metal or plastic lining.

The second non-primary packaging (3) was an expanded polystyrene boxwith a cardboard exterior for sticking labels and lined in its interiorwith another cardboard layer to increase its heat-insulating capacity.The dimensions of the second non-primary packaging were 40 cm in width,40 cm in depth and 30 cm in height, with a thickness of 5 cm. The R_(μ)parameter in these experiments was, therefore, 0.43. Additionally, inorder to verify the advantages of the transport box (1) of the inventionwith respect to other containers, experiments were carried out for anadditional type of first non-primary packaging (2), representative ofthose used normally in the state of the art, comprised of low-densityexpanded polystyrene sheets inside compressed cardboard packaging, ofsimilar characteristics to the second non-primary packaging (3), butwith much thinner walls and with less volume. This packaging has beentermed type 1 (NPT1) in the experiment.

Additionally, filling material was disposed between the firstnon-primary packaging (2) and the second non-primary packaging (3) aswell as heat accumulators (5).

Afterwards, each of the three types of packaging was disposed in theinterior of the second non-primary packaging (3), the assembly wassubjected to a constant external temperature of 4° C. and its calorificcapacity was calculated in each of the three situations. The results arereflected in the time-temperature graph of FIG. 2, which shows that thecalorific capacity of the system with type 1 first non-primary packaging(2) is clearly superior to the systems with type 2 or type 3 firstnon-primary packaging (2), due to which it is unsuitable for the purposeof the invention.

With regard to type 2 and type 3 packaging, the results reflected thatboth receptacles showed greater thermal resistance than the packagingused up until that moment.

Additionally, it was verified that the difference between type 2 andtype 3 first non-primary packaging (2) stemmed from the fact that type3, due to its inner conductive lining, had greater inertia for thermalchange than type 2. In this manner, a change from a non-optimum to anoptimum external temperature would affect type 2 first non-primarypackaging (2) more quickly than that of type 3. Therefore, in mostcases, the system that would best adapt to the needs raised is thatwhich contains a type 2 first non-primary packaging (2).

Example 2 Study of the Shipment of Plates to validate Thermal andMechanical Resistance Experimented on a Real Route

In order to complete the experiment, it was decided to validate abiotechnological product produced and distributed by Advanced In VitroCell Technologies, S.L., a kit comprised of plates with Caco2 cellscultivated as monolayers over a CacoReady™ porous membrane subjected toa transport process on a real route. Disposing of this type of materialallowed us to carry out pre- and post-shipment quality controls againsta negative control (plates which have not undergone the shipmentprocess) and then draw conclusions. A special characteristic of saidplates is that a culture medium which is solid at room temperature butbecomes liquid at optimum culture temperatures (37° C.) is placed onthese prior to being shipped. The experiment included the followingstages: Barcelona—Tebubio (Paris)—Barcelona.

The data prior to the study were the following:

-   -   Temperatures below 15° C. during relatively extended time        periods negatively affect the cellular monolayer and,        particularly, its barrier properties.    -   Temperatures above 25° C. during relatively extended time        periods affect the physical condition of the transport system,        producing heterogeneous areas of different density that        negatively affect the cellular monolayer and, particularly, its        barrier properties.

Therefore, the study was based on the plates with a perfectly solidmeans of transport, maintained at a temperature of 20-22° C. at the timeof shipment. The objective was to verify whether the transport box (1)according to the invention minimized the impact of variations inexternal temperatures, thereby guaranteeing that the plates remainwithin the optimum temperature range as long as possible. For this, twoshipments were made articulated in the following manner:

-   -   Shipment 1 (2 plates): Sent on 25 Jan. 2005 and received on 27        Jan. 2005.

T_(max) (° C.) T_(min) (° C.) T_(mean) (° C.) Barcelona Airport 13 4 925 Jan. 2005 Paris Airport 6 1 4 26 Jan. 2005

-   -   Shipment 2 (2 plates): Sent on 8 Feb. 2005 and received on 10        Feb. 2005.

T_(max) (° C.) T_(min) (° C.) T_(mean) (° C.) Barcelona Airport 13 4 9 8Feb. 2005 Paris Airport 7 1 4 9 Feb. 2005

In both cases the same type of second non-primary packaging (3) wasused, the same filling material, the same type of heat accumulator withthe same temperature (37° C.) and similar external temperatures. Inshipment 1, a type 1 first non-primary packaging (2) was used and, inshipment 2, a type 2 first non-primary packaging (2) was used (seeExample 1 for the definition of type 1 and type 2 first non-primarypackaging (2)).

Upon the return of the plates these were liquefied and subjected to TEER(Trans-Epithelial Electric Resistance) and flow (%) on day 21 and 23quality controls. The results were subjected to an internal platesatisfaction control which allows a maximum of 10% of deficient bowlswithin the sample space (teer >1000 ohm·cm² and flow (%) <1), followedby a statistical dispersion analysis. The results 15 were the following:

Shipment 1:

-   1) Plates 1 and 2 are satisfactory for teer control on day 21 (plate    1: 24/24, plate 2: 23/24).-   2) Plate 1 is satisfactory and plate 2 is unsatisfactory for flow    percentage control on day 21 (plate 1: 11/12, plate 2: 0/12).-   3) Plates 1 and 2 are unsatisfactory for teer control on day 23    (plate 1: 7/12, plate 2: 4/12).-   4) Plates 1 and 2 are unsatisfactory for flow percentage control on    day 23 (plate 1: 7/12, plate 2: 7/12).-   5) On day 21, the average teer of the bowls (optimum and    non-optimum) of plates 1 and 2 is respectively 35.12% and 34.20%    lower than the negative batch control (not shipped).-   6) On day 23, the average teer of the bowls (optimum and    non-optimum) of plates 1 and 2 is respectively 24.37% and 57.52%    lower than the negative batch control (not shipped).-   7) On day 21, the average flow (%) of the bowls (optimum and    non-optimum) of plates 1 and 2 is respectively 20% and 700.24%    higher than the negative batch control (not shipped).-   8) On day 23, the average flow (%) of the bowls (optimum and    non-optimum) is respectively 358.3% and 566.6% higher than the    negative batch control (not shipped).

Shipment 2:

-   1′) Plates 1 and 2 are satisfactory for teer control on day 21    (plate 1: 24/24, plate 2: 24/24).-   2′) Plates 1 and 2 are satisfactory for flow percentage control on    day 21 (plate 1: 12/12, plate 2: 12/12).-   3′) Plates 1 and 2 are satisfactory for teer control on day 23    (plate 1: 12/12, plate 2: 12/12).-   4′) Plates 1 and 2 are satisfactory for flow percentage control on    day 23 (plate 1: 12/12, plate 2: 12/12).-   5′) On day 21, the average teer of the bowls (all are optimum) of    plates 1 and 2 is respectively 8.5% and 4.2% lower than the negative    batch control (not shipped).-   6′) On day 23, the average teer of the bowls (all are optimum) of    plates 1 and 2 is respectively 6.18% and 10.2% lower than the    negative batch control (not shipped).-   7′) On day 21, the average flow (%) of the bowls (all are optimum)    of plates 1 and 2 is respectively 15% and 45.45% lower than the    negative batch control (not shipped).-   8′) On day 23, the average flow (%) of the bowls (all are optimum)    of plates 1 and 2 is respectively 45.45% and 27.27% lower than the    negative batch control (not shipped).

Conclusions:

-   -   For external temperatures above 10° C. and below 30° C. the        transport box (1) of the invention guarantees optimum internal        temperatures for time periods longer than 96 hours.    -   For temperatures between 5° C. and 10° C. the transport box (1)        of the invention guarantees optimum internal temperatures during        12 hours.    -   For temperatures between 0° C. and 5° C. the transport box (1)        of the invention guarantees optimum internal temperatures during        4-6 hours.    -   The transport box (1) of the invention has good thermal        recovery, in such a manner that, when exposed to external        temperatures of 20-25° C., the temperature inside the box rises        from the initial 4° C. to 18-20° C. after two hours.

Example 3 Study of Shipment without Plates on theBarcelona-Tebubio-Denmark-Barcelona Route

This study was carried out to verify the conclusions mentioned inexample 2.

For this reason it was decided to make a shipment without plates,measuring the temperature in the interior of the first non-primarypackaging (2) of a transport box (1) according to the invention on theBarcelona-Tebubio-Denmark-Barcelona route.

1. Route 1. Barcelona-Tebubio:

-   -   Package shipped on 15 Feb. 2005 and received on 16 Feb. 2005.        The time-temperature graph of this route is shown in FIG. 3.

T_(max) (° C.) T_(min) (° C.) T_(mean) (° C.) Barcelona Airport 14 5 915 Feb. 2005 Paris Airport 7 1 2 16 Feb. 2005

-   -   Initial temperature of the heat accumulator=37° C.    -   Duration of journey=16 hours.    -   Time of permanence inside the first non-primary packaging (2)        within the optimum temperature range of the product=10 hours.    -   Time of permanence inside the first non-primary packaging (2)        within the temperature range between 25° C. and 30° C.=6 hours.    -   Time of permanence inside the first non-primary packaging (2)        within the temperature range between 28° C. and 30° C.=2 hours.

Conclusions Route 1:

-   -   The time of permanence inside the first non-primary packaging        (2) within the temperature range between 28° C. and 30° C. is 2        hours, which is insufficient for the possible liquefaction of        the solid transport medium.    -   We can conclude that, during the whole route, the interior of        the first non-primary packaging (2) maintained its optimum        temperature conditions.

2. Route 2. Tebubio-Lyngby (Denmark)

-   -   Package shipped on 16 Feb. 2005 and received on 17 Feb. 2005.        The time-temperature graph for this route is shown in FIG. 4.

T_(max) (° C.) T_(min) (° C.) T_(mean) (° C.) Paris Airport 7 1 4 16Feb. 2005 Lyngby 2 −2 0 17 Feb. 2005

-   -   Initial temperature of the gel (heat accumulator)=30° C.    -   Duration of journey=22 hours.    -   Time of permanence inside the first non-primary packaging (2)        within the optimum temperature range of the product=18 hours.    -   Time of permanence inside the first non-primary packaging (2) at        temperatures below 15° C.=4 hours.    -   Minimum temperature reached by the system=12° C.

Conclusions Route 2:

-   -   There were no liquefaction problems with the solid transport        medium because the temperature never rose above 26° C. (maximum        temperature=25.9° C.).    -   Despite the fact that the interior of the first non-primary        packaging (2) maintained a temperature below 15° C. for 4 hours,        this is not considered critical for the system (although it        would be for temperatures below 10° C.).

The comparative time-temperature graph comparing the two routes is shownin FIG. 5.

1. A transport box (1) for transporting biological products thatcomprises: a hermetic first non-primary packaging (2) manufactured froma high-capacity heat-insulating plastic material; a second non-primarypackaging (3) that contains the first non-primary packaging (2),manufactured from high-density polystyrene; a third non-primarypackaging (4) that contains the second non-primary packaging (3), tosustain the structure, increase thermal resistance and bear thelabelling; one or several heat accumulators (5) disposed in the interiorof the first non-primary packaging (2) and/or between the firstnon-primary packaging (2) and the second non-primary packaging (3);characterized in that the relation (R_(μ)) between the volume of airbetween the first non-primary packaging (2) and the second non-primarypackaging (3) and the total volume of the box is in a range between 0.1and 0.6 and the thickness of the second non-primary packaging (3) is ina range between 4 and 6 cm.
 2. The transport box (1) for transportingbiological products according to claim 1, characterized in that thefirst non-primary packaging (2) has an inner metal lining.
 3. Thetransport box (1) for transporting biological products according toclaim 1, characterized in that the interior of the second non-primarypackaging (3) is lined with a layer of heat-insulating material.
 4. Thetransport box (1) for transporting biological products according toclaim 1, further comprising filling material, disposed in the interiorof the first non-primary packaging (2), between the first non-primarypackaging (2) and the second non-primary packaging (3), or in both. 5.The transport box (1) for transporting biological products according toclaim 1, characterized in that the second non-primary packaging (3) andthe third non-primary packaging (4) are combined, forming a singlepackaging with a polystyrene interior and cardboard exterior.
 6. Thetransport box (1) for transporting biological products according toclaim 1, characterized in that R_(μ) is in a range between 0.2 and 0.5.7. The transport box (1) for transporting biological products accordingto claim 6, characterized in that R_(μ) is in a range between 0.2 and0.3.
 8. The transport box (1) for transporting biological productsaccording to claim 1, characterized in that the thickness of the secondnon-primary packaging (3) is in a range between 4.5 and 5.5 cm.
 9. Thetransport box (1) for transporting biological products according toclaim 8, characterized in that the thickness of the second non-primarypackaging (3) is 5 cm.
 10. The transport box (1) for transportingbiological products according to claim 1, characterized in that thefirst non-primary packaging (2) has a cylindrical shape.
 11. Thetransport box (1) for transporting biological products according toclaim 1, characterized in that the second non-primary packaging (3) is aparallelepiped 30 cm in width×30 cm in length×20 cm in height.
 12. Thetransport box (1) for transporting biological products according toclaim 1, characterized in that the second non-primary packaging (3) is aparallelepiped 40 cm in width×40 cm in length×30 in height.